NMT STARFlex Single-Arm Study Insufficient For Approval, Panel Concludes
This article was originally published in The Gray Sheet
Executive Summary
NMT Medical must conduct a randomized controlled trial of the STARFlex septal occlusion system to demonstrate that the device is superior to medical therapy in preventing strokes, FDA's Circulatory System Devices Panel concluded at its Sept. 10 meeting in Gaithersburg, Maryland
You may also be interested in...
PFO Occluder Erosion, Post-Implant Thrombosis Indicate Caution Warranted
Post-implant problems associated with patent foramen ovale (PFO) and atrial septal defect (ASD) devices, including potential thrombosis and device erosion, need to be overcome before the technology can be universally applied, according to TCT participants
PFO Occluder Erosion, Post-Implant Thrombosis Indicate Caution Warranted
Post-implant problems associated with patent foramen ovale (PFO) and atrial septal defect (ASD) devices, including potential thrombosis and device erosion, need to be overcome before the technology can be universally applied, according to TCT participants
AGA Medical RESPECT Amplatzer PFO Trial To Include 500-800 Patients
AGA Medical anticipates its recently launched RESPECT trial will support implantation of the Amplatzer PFO Occluder after a single PFO-related stroke or TIA